Kornimate/medical-research-clean huggingface dataset:
the effect on self-care and self-efficacy of inhaler training in copd

Conditions: COPD

Summary: this study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level.

pulmonary diseases are a major source of mortality and morbidity globally. the major symptom of copd is dyspnea. since dyspnea leads to activity limitation and inadequate self-care skills among individuals, it is often associated with major psychological comorbidity, social isolation and poor perceived quality of life. copd patients with high self-efficacy are high enough to level of treatment adherence. on the other hand, the most preferred treatment method for the management and mitigation of copd symptoms is by the use of inhaler medication. however, incorrect use of the inhaler would lead to failure in the control of copd patients. also, it fails to provide copd patients with self-care agency and self-efficacy levels. in copd, planned inhaler medication training has been shown in many studies to reduce dyspnoea, increase self-care and self-efficacy levels. therefore, planned inhaler medication training increases quality of life in copd patients.

Eligibility criteria:
inclusion criteria: * subjects who are literate, * diagnosed with copd at least six months ago, * using inhaler medication since three or more months, * moderate or severe copd, according to gold criteria, * incorrect use inhaler medication uses according to the list of inhaler medication use skills, * no communication problems, * no mental confusion or any psychiatric problem, * agrees to participate in the study. exclusion criteria: * cognitive dysfunction, * severe pulmonary, cardiological or malignant disease, * in a period of exacerbation, * correctly performs all steps for their prescribed inhaler medication(s), according to the list of inhaler skills.

Keywords: copd dyspnea self-efficacy self-care
a storage facility for tissues obtained from patients with malignant melanoma

Conditions: Melanoma

Summary: this study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. the purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease.

primary objective: i. facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma. outline: patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. healthy individuals undergo collection of blood samples up to 4 times over 1 year.

Eligibility criteria:
inclusion criteria: * patient with malignant melanoma or personal history of melanoma * normal donors * informed consent can be obtained * patients with any stage of malignant melanoma exclusion criteria: * incarcerated individuals will be excluded from this protocol
the evolution of memories across wake and sleep

Conditions: Sleep Deprivation; Sleep

Summary: to further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the eeg signal, and (3) what stages and features of sleep affect memory evolution. together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.

goal 1: how do memories evolve across wake and sleep? the investigators are interested in how specific memories are selected for change across periods of wake and sleep, and in characterizing the manner in which those memories change. there has been research into broad areas of memory, such as procedural and declarative memory, but other forms of memory, such as semantic memory, remain unexplored, as well as different subtypes of memory within these broad areas. additionally, it is presently unknown how memories are selected for subsequent processing during sleep and wake. the investigators aim to characterize which memories change, how they are selected, and how they change differently over periods that include sleep versus periods during which participants remain awake. goal 2: how are these changes reflected behaviorally and in the eeg signal? the investigators will employ and develop specific behavioral and electrophysiological tasks and measures that allow one to probe the state of a particular type of memory and determine how it changes over periods of wake and sleep. eeg signals may be informative about the status of a memory during behavioral performance as well as during both waking and sleeping offline states. goal 3: what stages and features of sleep affect memory evolution? in the cases in which sleep in particular is found or suspected to influence memories in a unique way, the investigators will assess which stages and features of sleep are involved in that evolution. generally, this will be accomplished by correlating measures such as time spent in a sleep stage, prominence of particular brain oscillations, or density of spindles with changes in behavior or in other eeg metrics

Eligibility criteria:
inclusion criteria: * willing and able to follow the protocol * willing to refrain from alcohol and recreational drugs for the duration of the protocol * in some cases, english as a first language, normal hearing, and/or normal or corrected to normal vision is required exclusion criteria: * self-reported sleep disturbances * a history of mental illness * the use of any drugs that could affect either sleep or cognitive functioning (e.g., sleeping pills or antidepressants)

Keywords: sleep memory rem sleep slow wave sleep cognition sleep spindles
nurse amie (addressing malignancies in individuals everyday)

Conditions: Cancer

Summary: nurse amie 3.0 is testing the effectiveness of an electronic symptom management system on overall survival in people with stage 3 and 4 cancer who live in rural areas.

after being informed about the details of the study, including risks and potential benefits, participants who give their informed consent will do baseline measurements. after these measures are collected, participants will be randomly assigned to either receive the computer tablet nurse amie program or a supportive care book. participants will be asked to complete measurements throughout the course of their active participation, which will last for 2 years.

Eligibility criteria:
inclusion criteria: 1. patient receiving care for their cancer 2. age: 18+ years of age 3. has stage 3 or 4 cancer, or an unstaged cancer that is considered 'advanced' (greater than stage 2) by their treating oncologist 4. must be within six months of initiation of pharmacologic or radiation treatment, for curative or palliative purposes, from a medical or radiation oncologist 5. clinician-rated ecog function of 0-3 6. lives in a county with rucc code 4 - 9 and/or zip code with ruca code 4-10 7. has access to personal device capable of receiving telephone calls for study facilitator check-ins 8. fluent in written and spoken english 9. sufficient vision/hearing to interact with the tablet and study staff 10. clinician-defined life expectancy of 6 months or more exclusion criteria: 1. patients with medical or psychiatric conditions documented in the medical record (beyond cancer, its treatments, and its symptoms) that would impair our ability to test study hypotheses (e.g. psychotic disorders, dementia, inability to give informed consent, or follow study instructions). 2. patients who are participating in any other supportive care or behavioral intervention studies. 3. non-english speaking patients will be excluded, as they represent less than 2% of the population targeted.

Keywords: supportive care digital health physical activity symptom management
low fodmap diet in patients with ibs

Conditions: Irritable Bowel Syndrome

Summary: the aim was aimed to investigate if all carbohydrate groups eliminated in the low fodmap diet are equally important in relieving gastrointestinal symptoms in ibs. in a randomized cross-over design to three different carbohydrate-modified diets: a) low polyol diet, b) low fos+gos diet, and c) low fodmap diet for three months without wash-out-periods. gastrointestinal symptoms, quality of life was measured at baseline and after each intervention diet.

low fodmap diets contain 3 major types of carbohydrates to be avoided. the clasical diet is very difficult to maintain over longer periods of time. therefore, we aimed to investigate if all carbohydrate groups in the low fodmap diet are equally important in relieving gastrointestinal symptoms in ibs. patients diagnosed with ibs according to the rome iii criteria were randomised in a cross-over design to three different carbohydrate-modified diets: a) low polyol diet, b) low fos+gos diet, and c) low fodmap diet for a total of three months without wash-out-periods. gastrointestinal symptoms were assessed by the birmingham ibs questionnaire and adequate relief (ibs-ar). quality of life was measured by the ibs quality of life scale questionnaire (ibs-qol). all registrations were performed at baseline and after each intervention diet.

Eligibility criteria:
inclusion criteria: * ibs diagnosed by the rome iii criteria and * referred to the clinic for treatment by diet exclusion criteria: * dementia * lack of ability to speak danish * additional chronic diseases prevailing participation

Keywords: carbohydrates low fodmap diet components in the low fodmap diet
metabolomic and gut microbial biomarkers of smoking cessation treatment in long-term drug therapy: a randomized controlled trial

Conditions: Substance Use Disorder (SUD); Alcohol Use Disorder (AUD); Nicotine Addiction

Summary: theoretical framework: cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with substance use disorders (sud). smoking exacerbates both physical and mental health issues, further complicating the treatment of sud. current therapeutic approaches for sud often prove inadequate, indicating a need for new strategies. recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction. objectives: this study aims to investigate the therapeutic potential of smoking cessation for individuals with sud, using a six-week intervention within a therapeutic community. the research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. it is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems. methods: a randomized controlled trial (n=100) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. participants will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. assessments on a behavioural level will take place at a 3-months follow-up.


Eligibility criteria:
inclusion criteria: informed consent, a diagnosis of a form of substance use disorder (f1x.x) by a licensed psychiatrist according to icd-10, minimum age of 18 years, sufficient knowledge of the german language, willingness to quit smoking. - exclusion criteria: lack of consent, age below 18, inability to provide informed consent, acute psychotic symptoms or acute suicidal tendencies, cardiovascular disease, pregnancy or breastfeeding, severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (mini mental score \<20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy), probiotic intake within the last 6 months, or those consuming dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study, prior participation in a smoking cessation programme. -

Keywords: metabolomics gut microbiome substance use disorder nicotine addiction smoking cessation
this is a study to evaluate a pre-confectioned plantar insole for the treatment of plantar heel pain

Conditions: Plantar Fascitis

Summary: patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year. the aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life.


Eligibility criteria:
inclusion criteria: male and female adults * age ranging 18 to 70 years * patients with a history of at least 6 months of plantar fasciitis resistant to other conventional therapies * willingness and ability to participate in the trial * informed consent signed by the subject exclusion criteria: * diabetes mellitus not controlled pharmacologically * rheumatoid arthritis * previous foot surgery * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
economic evaluation of femtosecond laser assisted cataract surgery

Conditions: Cataract

Summary: cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in france. a new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the french healthcare insurance.

an estimated 700,000 cataract procedures are performed every year in france, with this amount of surgeries predicted to climb as the population there, as well as around the world, ages. currently, phacoemulsification alone is the conventional cataract surgery. the femtosecond laser-assisted cataract surgery has to be compared with the standard process to provide information on how it could benefit the patient population treated every year for cataract surgery. this economic study has received a grant from the french ministry of health to evaluate the economic impact of femtosecond laser-assisted process for the french healthcare system. for this goal, this prospective, randomized, parallel, multicenter and simple blind study will determine the incremental cost/effectiveness ratio for femtosecond laser-assisted process versus phacoemulsification surgery. visual acuity results and intraoperative or postoperative complication rate will be compared between both groups. the learning curve of the femtosecond laser assisted cataract surgery will be also evaluated for each surgeon involved in the study. ethic and regulatory autority authorisations were obtained at 19/dec/2012 and 15/feb/2013, respectively. date of first inclusion: 9/oct/2013. date of first nct release: 13/nov/2013. 30 patients were included between this period. french regulatory process dos not require nct registration before first inclusion.

Eligibility criteria:
inclusion criteria: * cataract with impaired visual acuity (\> or equal +0.3 logmar) or with cataract-related visual symptoms (halos, monocular diplopia, glare) * french healthcare insurance beneficiary exclusion criteria: * pupil size lower than 6mm * iris constriction * iris synechiae * preoperative zonular instability or crystalline lens subluxation * obstructive corneal scars * obstructive pterygion * axial length \<20.5 mm * corneal astigmatism \>1.5 diopters * fuchs corneal dystrophy * history of central retinal vein or artery occlusion * history of uveitis * history of optic nerve head neuropathy except glaucoma * progressive glaucoma * nystagmus * uncontrolled diabetes mellitus * general history of dementia or psychotic disorders * pregnancy, breast feeding * general medications: alpha-blockers, carbonic anhydrase inhibitors

Keywords: cataract surgery femtosecond laser cataract surgery phacoemulsification cost-benefit analysis cost effectiveness hospital costs
safety and efficacy of six months dual antiplatelet therapy after drug-eluting stenting

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after des implantation is not inferior to that of a 12 month therapy.

drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after des implantation is needed. however, no studies have been done to investigate which is the optimal antiplatelet therapy duration after des implantation. therefore, the objective of the randomized, double-blind, placebo-controlled isar-safe study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after des implantation. patients on clopidogrel therapy at least 6 months after des implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. the patients will be followed-up for 9 months after randomization.

Eligibility criteria:
inclusion criteria: * patients on clopidogrel therapy at 6 months (-1/+2 months) after des implantation * informed, written consent by the patient exclusion criteria: * age ≤18 years * clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization * previous stent thrombosis * des in left main coronary artery * st-elevation and non-st-elevation myocardial infarction during the last 6 months * malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance * planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy * active bleeding; bleeding diathesis; history intracranial bleeding * oral anticoagulation therapy with coumadin derivatives * known allergy or intolerance to the study medications: aspirin and clopidogrel * pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory) * patient's inability to fully comply with the study protocol * prior enrollment in the same clinical trial.

Keywords: clopidogrel drug-eluting stent
regular aquatic activities and pregnancy outcomes

Conditions: Weight Gain

Summary: aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.

the aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.

Eligibility criteria:
inclusion criteria: * healthy pregnant women without any medical or obstetric complication to practice moderate exercise * being able to communicate in spanish exclusion criteria: * being interesting in the study after 16 weeks of gestation * having obstetric contraindications * not attended regular to the exercise program

Keywords: aquatic activities aerobic exercise resistance exercise pregnancy maternal weight gain birthweight
feasibility controlled trial of an 8-session group intervention for siblings of children who have asd

Conditions: Autism Spectrum Disorder

Summary: a feasibility controlled trial of an eight-session group intervention for siblings of children who have an autism spectrum disorder (asd). children will be recruited from a multi-academy trust of nine schools. due to the on-going impact of covid-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. pre and post outcome measures will be completed by children and their parents in both research arms.


Eligibility criteria:
inclusion criteria: 1. 7-11 years old. 2. must have a sibling who has a formal diagnosis of asd. 3. must be competent in the english language. 4. must be in mainstream education. 5. must be willing and able to engage in an eight-session group intervention (including being accompanied to and from the group by their parents/carers). 6. must be registered with a gp and parental consent gained to inform the gp that the sibling is attending the group. exclusion criteria: 1. if the sibling has a diagnosis of asd themselves. 2. if there are any clear risk concerns (e.g. any thought or intent to harm self or others, involvement in court proceedings or with the criminal justice system). 3. if the sibling is currently receiving any other psychological treatment. 4. if the sibling has a learning disability or difficulty that will make it hard to access the group content and/or capacity to provide informed consent.
trials comparing of hd versus 4k laparoscopy for gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to explore the feasibility of 4k laparoscopic surgery for gastric cancer.

a prospective randomized comparison of hd and 4k laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4k laparoscopic technique. the evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria: * (1)age from over 19 to under 74 years * (2)ct 1-4a(clinical stage tumor), n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition * (3)heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications * (4)preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs * (5)american society of anesthesiology (asa) score class i, ii, or iii * (6)written informed consent exclusion criteria: * (1)women during pregnancy or breast-feeding * (2)severe mental disorder * (3)history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * (4)enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels * (5)history of unstable angina or myocardial infarction within past six months * (6)history of cerebrovascular accident within past six months * (7)history of continuous systematic administration of corticosteroids within one month * (8)history of previous neoadjuvant chemotherapy or radiotherapy * (9)t4b tumors * (10)emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * (11)fev1(forced expiratory volume in one second)#50% of predicted values

Keywords: stomach neoplasms laparoscopy